Bioequivalence Study of Sumatriptan Succinate Tablets 100 mg in Fed Conditions

NCT01269281 | Completed Phase 1

• 1 other identifier: BA0559019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to compare the relative bioavailability of Sumatriptan Succinate Tablets 100 mg with Imitrex Tablets 100 mg under fed conditions in healthy adult human subjects.

Conditions

Healthy

Keywords

Bioequivalence; two way crossover

Outcome Measures

Primary Outcomes (1)

• Bioequivalence based on Cmax and AUCt and AUCi parameters

  4 months

Study Arms (2)

Sumatriptan Succinate tablets 100 mg

EXPERIMENTAL

Sumatriptan Succinate tablets 100 mg of Dr.Reddy's Laboratories Limited

Drug: Sumatriptan

Imitrex 100 mg Tablets

ACTIVE COMPARATOR

Imitrex 100 mg Tablets of Glaxosmithkline

Drug: Sumatriptan

Interventions

Sumatriptan DRUG

Sumatriptan Succinate Tablets 100 mg

Also known as: Imitrex

Imitrex 100 mg Tablets; Sumatriptan Succinate tablets 100 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subjects should be healthy males between 18 and 45 years.
• The subjects should be screened within 21 days prior to the administration of first dose of the study..
• The subjects should have a BMI between 18 and 25 kg/m2
• The subjects should be able to communicate effectively with study personnel
• The subjects should be literate and able to give consent
• If subject is a female volunteer and
• Is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device(IUD), or abstinence
• Is postmenopausal for at least 1 year
• Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).

You may not qualify if:

• The subjects who have a history of allergic responses to Sumatriptan or other related drugs
• The subjects who have history of intake of MAOI within two weeks of dosing
• The subjects who have history of drug dependence, recent history of alcoholism or of moderate alcohol uses..
• The subjects who have significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG, and X-ray recordings..
• The subjects who have any disease or condition which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or glaucoma or any other body system.
• The subjects who have a history or presence of asthma (including aspirin induced asthma) or nasal polyp..
• The subjects who are smokers and who smoke more than 10 cigarettes/day or those who cannot refrain from smoking during study period..
• The subjects with a history of difficulty with donating blood or difficulty in accessibility of veins..
• The subjects who have donated 01 unit (350 ml / 450 ml) blood within 90 days prior to receiving the first dose of study medication (if blood loss is below or equal to 200mL, subjects can be enrolled in the trial after 60 days of donation).
• The subject who has a positive hepatitis screen including hepatitis B surface antigen, anti HCV, anti HEV.
• The subject who has a positive test result for HIV antibody and / or syphilis (RPR/VDRL).
• An unusual diet, for whatever reason (e .g. low sodium) for four weeks prior to receiving the study medication and throughout the subject's participation in the study.
• Female volunteers demonstrating a positive pregnancy screen.
• Female volunteers who are currently breast- feeding.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

BA Research India Limited

Bodakdev, Ahmedabad, 380 054, India

Location

MeSH Terms

Interventions

Sumatriptan

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Roma Choudhury, MBBS

  BA Research India Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 4, 2011
• Study Start: July 1, 2005
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: January 4, 2011

Record last verified: 2005-10

Locations

IN (1)